Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03782376 | A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease | PHASE3 | COMPLETED | 215 | — | — | Dec 20, 2018 | Jan 10, 2023 | Apr 29, 2025 | 104 | United States, Austria +10 |
Clinical response was defined as greater than or equal to (\>=) 100-point reduction from baseline in Crohn's disease activity index (CDAI) score or a CDAI score \< 150 points. CDAI is validated multi-item measure of severity of illness derived as weighted sum of 8 different Crohn's disease (CD)-related variables (extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being). The last 4 variables were scored over 7 days by participant on diary card. In general, CDAI score ranges from 0 to approximately 600; higher score=higher disease activities. Participants who had prohibited CD-related surgery, prohibited concomitant medication changes or discontinued study agent due to lack of efficacy or adverse event indicated to be of worsening CD prior to designated analysis timepoint were considered not to be in clinical response, regardless of their CDAI score.
| Arm | Type | Description |
|---|---|---|
| Group 1: Ustekinumab (IV re-induction) | EXPERIMENTAL | Participants who experience a secondary loss of response (LoR) to 90 mg ustekinumab maintenance treatment, administered subcutaneously every 8 weeks (q8w) will receive a weight-tiered based ustekinumab IV re-induction dose of approximately 6 mg/kg and matching placebo subcutaneously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician. |
| Group 2: Ustekinumab (Continuous q8w SC maintenance) | ACTIVE_COMPARATOR | Participants who experience a secondary LoR to 90 mg ustekinumab maintenance treatment, administered subcutaneously q8w will receive ustekinumab 90 mg subcutaneously and matching placebo intravenously at Week 0. At Weeks 8 and 16, all participants will receive SC maintenance injections of 90 mg ustekinumab. Participants will resume their standard-of-care therapy at Week 24 at the discretion of the treating physician. |
| Name | Type | Description |
|---|---|---|
| Ustekinumab approximately 6 mg/kg (IV) | DRUG | Participants will receive ustekinumab approximately 6mg/kg intravenously at Week 0. |
| Placebo (SC) | DRUG | Participants will receive SC injection of placebo at Week 0. |
| Placebo (IV) | DRUG | Participants will receive IV infusion of placebo at Week 0. |
| Ustekinumab 90 mg (SC) Group 1 | DRUG | Participants will receive SC injection of ustekinumab 90 mg at Weeks 8 and 16. |
| Ustekinumab 90 mg (SC) Group 2 | DRUG | Participants will receive SC injection of ustekinumab 90 mg at Weeks 0, 8 and 16. |
Inclusion criteria: * A history of Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy * Currently receiving subcutaneous 90 mg every 8 weeks (q8w) ustekin...